17394 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 

1Accounting and Financial Reporting for Public 

Utilities Including RTOs, Order No. 668, FERC 

Stats. & Regs. ¶ 31,199 (2005), reh’g denied, Order 

No. 668–A, FERC Stats. & Regs. ¶ 31,215 (2006), 

reh’g denied, 117 FERC ¶ 61,066 (2006). 

1A large number of these form letters were 

submitted after the close of the objection period. 

Tardy objections fail to satisfy the requirements of 

21 U.S.C. 348(f)(1) and need not be considered by 

the agency (ICMAD v. HEW, 574 F.2d 553, 558 n.8 

(D.C. Cir), cert. denied, 439 U.S. 893 (1978)). 

regional transmission organizations.1

Order No. 668 amended FERC Form 

Nos. 1 and 1–F by adding new 

schedules and revising existing 

schedules in the forms. The 

Commission updated the submission 

software used to file FERC Form Nos. 1 

and 1–F to reflect the new financial 

reporting requirements of Order No. 

668. 

The annual filing date for FERC Form 

Nos. 1 and 1–F is April 18. However, in 

light of the software changes made to 

implement Order No. 668, the filing 

deadline for the 2006 FERC Form Nos. 

1 and 1–F is extended until May 18, 

2007. 

Philis J. Posey, 

Acting Secretary. 

[FR Doc. E7–6511 Filed 4–6–07; 8:45 am] 

BILLING CODE 6717–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 179 

[Docket No. 2003F–0088 (formerly 03F–

0088)] 

Irradiation in the Production, 

Processing and Handling of Food 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; response to 

objections and denial of requests for a 

hearing. 

SUMMARY: The Food and Drug 

Administration (FDA) is responding to 

objections and is denying requests that 

it has received for a hearing on the final 

rule that amended the food additive 

regulations by establishing a new 

maximum permitted energy level of xrays for treating food of 7.5 million 

electron volts (MeV) provided that the 

x-rays are generated from machine 

sources that use tantalum or gold as the 

target material, with no change in the 

maximum permitted dose levels or uses 

currently permitted by FDA’s food 

additive regulations. After reviewing the 

objections to the final rule and the 

requests for a hearing, the agency has 

concluded that the objections do not 

raise issues of material fact that justify 

a hearing or otherwise provide a basis 

for removing the amendment to the 

regulation. 

FOR FURTHER INFORMATION CONTACT: 

Andrew J. Zajac, Center for Food Safety 

and Applied Nutrition (HFS–265), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740–

3835, 301–436–1267. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

FDA published a notice in the Federal 

Register of March 13, 2003 (68 FR 

12087), announcing the filing of food 

additive petition, FAP 3M4745, by Ion 

Beam Applications to amend the food 

additive regulations in § 179.26 Ionizing 

radiation for the treatment of food (21 

CFR 179.26) by increasing the maximum 

permitted energy level of x-rays for 

treating food from 5 to 7.5 MeV. The 

rights to this petition were subsequently 

transferred to Sterigenics International, 

Inc. In response to this petition, FDA 

issued a final rule in the Federal 

Register of December 23, 2004 (69 FR 

76844) permitting the safe use of 7.5 

MeV x-rays for treating food provided 

that the x-rays are generated from 

machine sources that use tantalum or 

gold as the target material, with no 

change in the maximum permitted dose 

levels or uses currently permitted by 

FDA’s food additive regulations (the 7.5 

MeV x-ray final rule). The preamble to 

the final rule advised that objections to 

the final rule and requests for a hearing 

were due within 30 days of the 

publication date (i.e., by January 24, 

2005). 

II. Objections and Requests for a 

Hearing 

Section 409(f) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 348(f)) provides that, within 30 

days after publication of an order 

relating to a food additive regulation, 

any person adversely affected by such 

order may file objections, specifying 

with particularity the provisions of the 

order ‘‘deemed objectionable, stating 

reasonable grounds therefore, and 

requesting a public hearing upon such 

objections.’’ FDA may deny a hearing 

request if the objections to the 

regulation do not raise genuine and 

substantial issues of fact that can be 

resolved at a hearing (Community 

Nutrition Institute v. Young, 773 F.2d 

1356, 1364 (D.C. Cir. 1985), cert. denied, 

475 U.S. 1123 (1986)). 

Under the food additive regulations at 

21 CFR 171.110, objections and requests 

for a hearing are governed by part 12 (21 

CFR part 12) of FDA’s regulations. 

Under § 12.22(a), each objection must 

meet the following conditions: (1) Must 

be submitted on or before the 30th day 

after the date of publication of the final 

rule; (2) must be separately numbered; 

(3) must specify with particularity the 

provision of the regulation or proposed 

order objected to; (4) must specifically 

state each objection on which a hearing 

is requested; failure to request a hearing 

on an objection constitutes a waiver of 

the right to a hearing on that objection; 

and (5) must include a detailed 

description and analysis of the factual 

information to be presented in support 

of the objection if a hearing is requested; 

failure to include a description and 

analysis for an objection constitutes a 

waiver of the right to a hearing on that 

objection. 

Following publication of the 7.5 MeV 

x-ray final rule, FDA received about 100 

objections within the 30-day objection 

period. All but one of these submissions 

expressed general opposition to 

increasing the maximum permitted 

energy level of x-rays used to irradiate 

food and to food irradiation. Most of 

these objections were form letters, 

identically worded, urging FDA to 

conduct additional studies on the effects 

of 7.5 MeV x-rays on food and objecting 

‘‘to the agency’s decision knowing that 

some amount of radioactivity could be 

created in food treated with 7.5 MeV.’’

While most of these objections 

requested a hearing, no evidence was 

submitted in support of these objections 

that could be considered in an 

evidentiary hearing. These submissions 

expressing general opposition raise no 

factual issue for resolution and, 

therefore, do not justify a hearing.1 The 

one submission raising specific 

objections was a letter from Public 

Citizen with six objections to the 7.5 

MeV x-ray final rule. The letter 

requested a hearing on issues raised by 

each objection. These objections are 

addressed in section IV of this 

document. 

III. Standards for Granting a Hearing 

Specific criteria for deciding whether 

to grant or deny a request for a hearing 

are set out in § 12.24(b). Under that 

regulation, a hearing will be granted if 

the material submitted by the requester 

shows, among other things, the 

following: (1) There is a genuine and 

substantial factual issue for resolution at 

a hearing; a hearing will not be granted 

on issues of policy or law; (2) the factual 

issue can be resolved by available and 

specifically identified reliable evidence; 

a hearing will not be granted on the 

basis of mere allegations or denials or 

general descriptions of positions and 


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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 17395 

contentions; (3) the data and 

information submitted, if established at 

a hearing, would be adequate to justify 

resolution of the factual issue in the way 

sought by the requestor; a hearing will 

be denied if the data and information 

submitted are insufficient to justify the 

factual determination urged, even if 

accurate; (4) resolution of the factual 

issue in the way sought by the person 

is adequate to justify the action 

requested; a hearing will not be granted 

on factual issues that are not 

determinative with respect to the action 

requested (e.g., if the action would be 

the same even if the factual issue were 

resolved in the way sought); (5) the 

action requested is not inconsistent with 

any provision in the act or any FDA 

regulation; and (6) the requirements in 

other applicable regulations, e.g., 21 

CFR 10.20, §§ 12.21, and 12.22, and in 

the notice issuing the final regulation or 

the notice of opportunity for hearing are 

met. 

A party seeking a hearing is required 

to meet a ‘‘threshold burden of 

tendering evidence suggesting the need 

for a hearing’’ (Costle v. Pacific Legal 

Foundation, 445 U.S. 198, 214–215 

(1980), reh. denied, 446 U.S. 947 (1980), 

citing Weinberger v. Hynson, Westcott & 

Dunning, Inc., 412 U.S. 609, 620–621 

(1973)). An allegation that a hearing is 

necessary to ‘‘sharpen the issues’’ or to 

‘‘fully develop the facts’’ does not meet 

this test (Georgia Pacific Corp. v. EPA, 

671 F.2d 1235, 1241 (9th Cir. 1982)). If 

a hearing request fails to identify any 

factual evidence that would be the 

subject of a hearing, there is no point in 

holding one. In judicial proceedings, a 

court is authorized to issue summary 

judgment without an evidentiary 

hearing whenever it finds that there are 

no genuine issues of material fact in 

dispute and a party is entitled to 

judgment as a matter of law (see Rule 

56, Federal Rules of Civil Procedure). 

The same principle applies in 

administrative proceedings (see § 12.28). 

A hearing request must not only 

contain evidence, but that evidence 

should raise a material issue of fact 

concerning which a meaningful hearing 

might be held (Pineapple Growers Ass’n 

v. FDA, 673 F.2d 1083, 1085 (9th 

Cir.1982)). Where the issues raised in 

the objection are, even if true, legally 

insufficient to alter the decision, the 

agency need not grant a hearing (see 

Dyestuffs and Chemicals, Inc. v. 

Flemming, 271 F.2d 281 (8th Cir. 1959), 

cert. denied, 362 U.S. 911 (1960)). FDA 

need not grant a hearing in each case 

where an objector submits additional 

information or posits a novel 

interpretation of existing information 

(see United States v. Consolidated 

Mines & Smelting Co., 455 F.2d 432 (9th 

Cir. 1971)). In other words, a hearing is 

justified only if the objections are made 

in good faith and if they ‘‘draw in 

question in a material way the 

underpinnings of the regulation at 

issue’’ (Pactra Industries v. CPSC, 555 

F.2d 677 (9th Cir. 1977)). Finally, courts 

have uniformly recognized that a 

hearing need not be held to resolve 

questions of law or policy (see Citizens 

for Allegan County, Inc. v. FPC, 414 

F.2d 1125 (D.C. Cir. 1969); Sun Oil Co. 

v. FPC, 256 F.2d 233, 240 (5th Cir.), cert. 

denied, 358 U.S. 872 (1958)). 

Even if the objections raise material 

issues of fact, FDA need not grant a 

hearing if those same issues were 

adequately raised and considered in an 

earlier proceeding. Once an issue has 

been so raised and considered, a party 

is estopped from raising that same issue 

in a later proceeding without new 

evidence. The various judicial doctrines 

dealing with finality can be validly 

applied to the administrative process. In 

explaining why these principles ‘‘self 

evidently’’ ought to apply to an agency 

proceeding, the U.S. Court of Appeals 

for the District of Columbia Circuit 

wrote: ‘‘The underlying concept is as 

simple as this: Justice requires that a 

party have a fair chance to present his 

position. But overall interests of 

administration do not require or 

generally contemplate that he will be 

given more than a fair opportunity.’’

Retail Clerks Union, Local 1401 v. 

NLRB, 463 F.2d 316, 322 (D.C. Cir. 

1972). (See Costle v. Pacific Legal 

Foundation, supra at 215–220. See also 

Pacific Seafarers, Inc. v. Pacific Far East 

Line, Inc., 404 F.2d 804 (D.C. Cir. 1968), 

cert. denied, 393 U.S. 1093 (1969).)) 

In summary, a hearing request must 

present sufficient credible evidence to 

raise a material issue of fact and the 

evidence must be adequate to resolve 

the issue as requested and to justify the 

action requested. 

IV. Analysis of Objections and 

Response to Hearing Requests 

The letter from Public Citizen raises 

six issues that they believe to be factual 

and requests a hearing based on these 

objections. FDA addresses each of the 

objections in the following paragraphs, 

as well as the evidence and information 

filed in support of each, comparing each 

objection and the information submitted 

in support of it to the standards for 

granting a hearing in § 12.24. 

(1) Public Citizen contends that FDA 

did not adequately account for the fact 

that an electron beam on an x-ray target 

is not monoenergetic, and that a 

significant portion of the beam may be 

higher than the nominal energy, 

resulting in higher neutron production 

in the food and more activity. Public 

Citizen cites a published paper in the 

petition in which the authors note that 

measurements and calculations of a 7.5 

MeV setting actually correspond to 8.1 

MeV 0.8 MeV. 

The objection does not raise a genuine 

and substantial issue of fact for 

resolution at a hearing. Contrary to the 

objection, the final rule does not set a 

‘‘nominal energy’’ limit. The final rule 

sets out 7.5 MeV as the maximum 

energy permitted. X-rays from machine 

sources at energies exceeding 7.5 MeV 

are not permitted by the final rule. 

Further, the objection provides no 

evidence to support the contention that 

safety concerns regarding inherent 

limitations on the precision of setting 

and measuring voltage were not 

considered. The paper referred to in the 

objection, Gregoire, O., Cleland, M.L., 

Wakeford, Mittendorfer, et al., 

‘‘Radiological Safety of Food Irradiation 

With High Energy X-Rays: Theoretical 

Expectations and Experimental 

Evidence,’’ 2002, was included as a 

reference in the final rule and counters 

the objection. The paper discusses the 

radiological implications of irradiating 

meat with 7.5 MeV x-rays to an x-ray 

dose of 15 kGy, which is more than 

twice the maximum dose allowed for 

meat irradiation (4.5 kGy maximum for 

refrigerated meat and 7.0 kGy maximum 

for frozen meat) (see § 179.26(b)). 

Experiments were performed with x-ray 

machines that use two different types of 

electron accelerators, one delivering 

electrons with a narrow electron energy 

spread, the other delivering a broad 

energy spread. The Gregoire paper 

concluded that risk to individuals from 

intake of food irradiated with x-rays 

from 7.5 MeV electrons, even with a 

broad energy spread, would be trivial. 

In the experiments discussed in the 

Gregoire paper, the equipment was set 

to achieve a voltage of 7.5 MeV. 

Measurements (including calculations) 

to verify the precision of the settings 

estimated that the machine produced 

electrons at an energy of approximately 

8.1 MeV, with an uncertainty margin of 

0.8 MeV. In other words, within the 

limits of precision of the measurements, 

the energy of the electrons used to 

produce the x-rays was shown to be 

greater than 7.3 MeV but less than 8.9 

MeV. FDA notes that even though the 

equipment in this experiment produced 

a higher energy level than permitted by 

the regulation, the results show that any 

radioactivity that might be induced at 

that higher energy level is trivially 

small. 

Public Citizen has not raised a 

genuine and substantial issue of fact and 


rwilkins on PROD1PC63 with RULES
17396 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 

2Public Citizen incorrectly states in their 

objection that the cancer risk estimated by the 

author is 0.08 per million. 

has not provided any information that 

contradicts the agency’s safety 

determination. Thus, a hearing is not 

justified based on this objection 

(§ 12.24(b)(1) and (2)). 

(2) Public Citizen claims that FDA has 

concluded that any induced activity in 

food from treating it with 7.5 MeV xrays is safe without a standard for a 

‘‘safe’’ level of induced activity in food 

and further objects to any additional 

radiation level in treated food. 

The objection does not cite any 

support for its contention that FDA 

must establish a general standard for a 

safe level of induced activity in food 

beyond the act’s requirements for food 

additive approvals. The use of x-rays to 

treat food is a food additive under the 

act’s definition of ‘‘food additive,’’

which includes any source of radiation 

intended for use in producing, 

manufacturing, packing, processing, 

preparing, treating, packaging, 

transporting, or holding food (section 

201(s) of the act) (21 U.S.C. 321(s)). 

Section 409 of the act requires that a 

regulation approving a food additive 

must prescribe, with respect to the 

proposed uses of the additive, the 

conditions under which the additive 

may be safely used. Further, section 409 

of the act sets out that no such 

regulation can issue if a fair evaluation 

of the data fails to establish that the 

proposed use of the food additive, under 

the conditions of use to be specified in 

the regulation, will be safe. FDA has 

defined ‘‘safe’’ and ‘‘safety’’ by 

regulation to mean that ‘‘there is a 

reasonable certainty in the minds of 

competent scientists that the substance 

is not harmful under the intended 

conditions of use.’’ (21 CFR 170.3(i)). 

In accordance with the requirements 

of section 409 of the act and the food 

additive regulations, FDA determined 

that food treated with 7.5 MeV x-rays is 

safe by comparing the total annual dose 

from eating irradiated foods with the 

annual dose from naturally occurring 

radionuclides in the food. FDA’s 

determination was based on its review 

of the data in the record, including the 

reports referenced in the final rule from 

the International Atomic Energy 

Agency, Gregoire et al., and the 

independent evaluation of the data by 

Oak Ridge National Laboratory. FDA 

concluded based on these analyses that 

any radioactivity that may be induced in 

any food treated with 7.5 MeV x-rays 

will be trivially low and that any 

potential human exposure due to 

consumption of irradiated food will be 

inconsequential compared to that from 

radionuclides that are present naturally 

in food. 

Public Citizen’s objection presents no 

factual evidence that FDA has 

overlooked in reaching the decision that 

7.5 MeV x-rays are safe for treating food 

under the conditions of use specified in 

the regulation. Thus, Public Citizen has 

failed to justify a hearing on this issue 

(§ 12.24(b)(2)). 

(3) Public Citizen objects to the 

agency’s approval of 7.5 MeV x-rays for 

treating food without assessing the risk 

of getting cancer from eating food with 

added radioactivity. The objection 

points to a paper by Ari Brynjolfsson, 

cited by the petitioner, which estimates 

the lifetime cancer risk from eating 

foods irradiated with 7.5 MeV x-rays to 

be 0.8 per million.2

FDA disagrees with Public Citizen’s 

assertion that it did not consider the risk 

of getting cancer from eating food 

treated with 7.5 MeV x-rays during its 

review of FAP 3M4745. As stated in the 

preamble of the rule, FDA contracted 

with Oak Ridge National Laboratory 

(ORNL) to perform an independent 

evaluation of the data in the 

administrative record, including an 

evaluation of cancer risk. The ORNL 

evaluation was placed in the docket 

when the rule published. ORNL 

concluded that because the factors used 

in the data in the administrative record 

to estimate cancer risk are based on 

much higher doses than permitted in 

the rule, the data in the administrative 

record, including the data in the 

Brynjolfsson paper, cannot be applied 

with any credibility to extrapolate 

cancer risk to the extremely low 

potential doses that a person might 

receive from consuming food treated 

with 7.5 MeV x-rays. The extrapolations 

that would be required would yield 

estimated risks far too small to reliably 

measure or verify. FDA agrees with this 

conclusion. 

The only evidence referenced by 

Public Citizen in support of its assertion 

is the Brynjolfsson paper, which was 

part of the administrative record and 

was considered in ORNL’s evaluation of 

the data and FDA’s safety 

determination. Therefore, Public Citizen 

has not identified any evidence to 

support its assertion that was not 

already considered by FDA in its safety 

determination. A hearing will not be 

granted on the basis of mere allegations 

or denials or general descriptions of 

positions and contentions (21 CFR 

12.24(b)(2)). 

(4) Public Citizen asserts that FDA did 

not comply with § 170.22 (21 CFR 

170.22), which states that a food 

additive will not be granted a tolerance 

that will exceed 1/100th of the 

maximum amount demonstrated to be 

without harm to experimental animals 

unless evidence is submitted which 

justifies use of a different safety factor. 

Public Citizen expresses the view that 

this non-compliance includes not only 

the failure to conduct any animal 

experiments using foods irradiated with 

7.5 MeV x-rays, but also the failure to 

calculate a 100-to-1 safety factor or 

submit evidence that justifies the use of 

a different safety factor. 

The objection does not include any 

evidence or support for the contention 

that animal experiments are required to 

be conducted to determine whether a 

proposed use of a food additive is safe. 

The safety criteria that must be 

considered by the agency before a food 

additive regulation is issued are listed 

in 21 U.S.C. 348(c)(5). The act does not 

prescribe what safety tests should be 

performed to determine whether an 

additive is safe. Public Citizen’s 

objection references the regulation in 

§ 170.22 which sets out a safety factor of 

100-to-1 in applying animal 

experimentation data to man (that is, the 

additive will not be approved for use in 

an amount greater than 1/100th of the 

maximum amount demonstrated to be 

without harm to experimental animals), 

unless evidence is submitted which 

justifies use of a difference safety factor. 

That regulation concerns how to apply 

animal experimentation data when it 

exists. It does not, however, require that 

animal testing be done in all food 

additive safety determinations. 

Because of the extremely low levels of 

induced radioactivity in food from the 

use of 7.5 MeV x-rays, it would not be 

possible to measure any toxicological 

effects from this induced activity in 

food fed to animals even with the most 

sensitive toxicological testing. 

Consequently, animal testing is neither 

necessary nor helpful to demonstrate 

the safety of food treated with 7.5 MeV 

x-rays. Rather, safety was demonstrated 

by showing that calculated estimates of 

radiation exposure from induced 

activity in food from the use of 7.5 MeV 

x-rays is far below the exposure from 

activity resulting from radionuclides 

that are present naturally in food. FDA 

concluded that such an analysis 

provides information that is far more 

sensitive to potential effects than can be 

obtained from the use of animal studies. 

Public Citizen has submitted no 

information to establish that the animal 

and other testing it recommended is 

required to demonstrate safety, or even 

that such testing would be valid to 

assess safety. Because Public Citizen 

provided no evidence to consider in 


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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 17397 

support of its assertion, FDA is denying 

the request for a hearing on this point 

because a hearing will not be granted on 

the basis of mere allegations or denials 

or general descriptions of positions and 

contentions (21 CFR 12.24(b)(2)). 

(5) Public Citizen asserts that by FDA 

failing to comply with § 170.22, FDA 

did not comply with § 170.20 (21 CFR 

170.20), which states that ‘‘the 

Commissioner will be guided by the 

principles and procedures for 

establishing the safety of food additives 

stated in current publications of the 

National Academy of Sciences National 

Research Council.’’

Section 170.22 pertains to safety 

factors to be applied to animal 

experimentation data in determining 

whether a proposed use of a food 

additive is safe. As discussed previously 

in item 4, no animal studies were 

necessary nor were any conducted to 

demonstrate that the use of 7.5 MeV xrays is safe for treating food. Because the 

provisions of § 170.22 do not apply to 

the agency’s review of FAP 3M4745, 

Public Citizen’s assertion that FDA did 

not comply with § 170.20 because it did 

not comply with § 170.22 is without 

merit. Therefore, this objection is not a 

basis for a hearing because there is no 

genuine and substantial issue of fact for 

resolution (§ 12.24(b)(1)). 

(6) Public Citizen asserts that FDA did 

not comply with 21 U.S.C. 348(c)(3)(A), 

which states that ‘‘No such regulation 

shall issue if a fair evaluation of the data 

before the Secretary—(A) fails to 

establish that the proposed use of the 

food additive, under the conditions of 

use to be specified in the regulation, 

will be safe: Provided, That no additive 

shall be deemed to be safe if it is found 

to induce cancer when ingested by 

man.’’ Nor has FDA complied with 

§ 170.3(i), which defines ‘‘safe’’ as 

‘‘there is a reasonable certainty in the 

minds of competent scientists that the 

substance is not harmful under the 

intended conditions of use.’’

Public Citizen has not provided any 

evidence to support these allegations or 

that contradicts or challenges the 

agency’s safety determination. The 

agency finds that this objection is 

merely a general description of Public 

Citizen’s position, and that it does not 

raise a factual issue for resolution at a 

hearing. Therefore, FDA is denying the 

requests for a hearing on this point 

because there is no genuine and 

substantial issue of fact for resolution at 

a hearing, and a hearing will not be 

granted on the basis of mere allegations 

or denials or general descriptions of 

positions and contentions (§ 12.24(b)(1) 

and (b)(2)). 

V. Summary and Conclusions 

Section 409 of the act requires that a 

food additive be shown to be safe prior 

to marketing. Under § 170.3(i), a food 

additive is ‘‘safe’’ if there is a reasonable 

certainty in the minds of competent 

scientists that the substance is not 

harmful under the intended conditions 

of use. In the final rule approving the 

use of 7.5 MeV x-rays for treating food, 

FDA concluded, based on its evaluation 

of the data submitted in the petition and 

other relevant material, that the use of 

7.5 MeV x-rays proposed in the petition 

for treating food is safe under the 

conditions set forth in the regulation 

codified at § 179.26. The petitioner has 

the burden to demonstrate the safety of 

the additive in order to gain FDA 

approval. Once FDA makes a finding of 

safety, the burden shifts to an objector, 

who must come forward with evidence 

that calls into question FDA’s 

conclusion (American Cyanamid Co. v. 

FDA, 606 F.2d 1307, 1314–1315 (D.C. 

Cir. 1979)). 

None of the objections received 

contained evidence to support a genuine 

and substantial issue of fact. Nor has 

any objector established that the agency 

overlooked significant information in 

reaching its conclusion. Therefore, the 

agency has determined that the 

objections that requested a hearing do 

not raise any substantial issue of fact 

that would justify an evidentiary 

hearing (§ 12.24(b)). Accordingly, FDA 

is not making any changes in response 

to the objections and is denying the 

requests for a hearing. 

Dated: March 27, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6646 Filed 4–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 803, 814, 820, 821, 822, 

874, 886, 1002, 1005, and 1020 

[Docket No. 2007N–0104] 

Medical Devices; Technical 

Amendment 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule; technical 

amendment. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending 

certain medical device regulations to 

correct typographical errors and to 

ensure accuracy and clarity in the 

agency’s regulations. 

EFFECTIVE DATE: April 9, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Philip Desjardins, Center for Devices 

and Radiological Health (HFZ–215), 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850, 240–

276–2343. 

SUPPLEMENTARY INFORMATION: FDA is 

amending its regulations in parts 803, 

814, 820, 821, 822, 874, 886, 1002, 1005, 

and 1020 to correct typographical errors, 

and update addresses, telephone 

numbers, and wording to ensure 

accuracy and clarity in the agencies 

medical device regulations. 

Publication of this document 

constitutes final action on these changes 

under the Administrative Procedure Act 

(5 U.S.C. 553). FDA has determined that 

notice and public comment are 

unnecessary because these errors are 

nonsubstantive. 

I. Highlights of the Final Rule 

FDA is making changes to correct 

typographical and other minor errors in 

certain device regulations in parts 803, 

814, 820, 821, 822, 874, 886, 1002, 1005, 

and 1020 (21 CFR 803, 814, 820, 821, 

822, 874, 886, 1002, 1005, and 1020). 

1. FDA is revising § 803.11 and 

replacing ‘‘301–443–8818’’ with ‘‘240–

276–3151.’’

2. FDA is revising § 803.11 and 

replacing ‘‘http://www.fda.gov/cdrh/ 

mdr/mdr-forms.html’’ with ‘‘http:// 

www.fda.gov/medwatch/getforms.htm.’’

3. FDA is revising § 803.21(a) and 

replacing ‘‘301–443–8818’’ with ‘‘240–

276–3151.’’

4. FDA is revising § 803.21(a) and 

replacing ‘‘http://www.fda.gov/cdrh/ 

mdr/373.html’’ with ‘‘http:// 

www.fda.gov/cdrh/mdr/mdrforms.html.’’

5. FDA is revising § 814.20(g) and 

replacing ‘‘FDA has issued a PMA 

guidance document to assist the 

applicant in the arrangement and 

content of a PMA. This guidance 

document is available on the Internet at 

http://www.fda.gov/cdrh/dsma/ 

pmaman/front.html. This guidance 

document is also available upon request 

from the Center for Devices and 

Radiological Health, Division of Small 

Manufacturers Assistance (HFZ–220), 

1350 Piccard Dr., Rockville, MD 20850, 

FAX 301–443–8818’’ with ‘‘Additional 

information on FDA policies and 

procedures, as well as links to PMA 

guidance documents, is available on the 

Internet at http://www.fda.gov/cdrh/ 

devadvice/pma/.’’

6. FDA is revising § 820.1(e) and 

replacing ‘‘Division of Small 


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